RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: NCT03498716 A Phase III, Multicenter, Randomized, Open-Label Study Comparing ATEZOLIZUMAB (Anti-PD-L1 Antibody) in Combination with Adjuvant ANTHRACYCLINE/TAXANE-Based Chemotherapy Versus Chemotherapy Alone in Patients with Operable Triple-Negative Breast Cancer

Status

Open

Description

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

Objective

The primary objective of Study BIG 16-05/AFT-27/WO39391 is to evaluate the efficacy of adjuvant treatment with atezolizumab T-AC/EC compared with T-AC/EC alone in patients with newly diagnosed TNBC as measured by iDFS.

Treatment

Experimental: Atezolizumab + Chemotherapy Participants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose. Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Active Comparator: Chemotherapy Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF). Paclitaxel will be administered by IV, 80 mg/m every week for 12 weeks.

Conditions

Breast

Phases

III

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Crozier, Jennifer

Practice

Breast

Scope

National

Participating Institutions

Baptist MD Anderson Cancer Center

Eligibility

Inclusion Criteria: - Non-metastatic operable Stage II-III breast cancer - Histologically documented TNBC (Triple Negative Breast Cancer) - Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen - Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy - Adequate hematologic and end-organ function - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. - No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization. - Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides. Exclusion Criteria: - Prior history of invasive breast cancer - For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy. - Previous therapy with anthracyclines or taxanes for any malignancy - Cardiopulmonary dysfunction - Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome - Active or history of autoimmune disease or immune deficiency - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan - Urinary outflow obstruction - Active tuberculosis - Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab) - Prior allogeneic stem cell or solid organ transplant - Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study

Nct ID Number

NCT03498716

Secondary Trial ID Number

BIG16-05/AFT-27/WO39391/IMPASSION

Keywords

Treatment

More Information

clinicaltrials.gov

“The support team gave not only me but my family a sense of peace.”

—David Smith, Patient

At Baptist MD Anderson, you can rely on our cancer experts to deliver the complex, coordinated care needed to address your condition. Learn more about Patricia’s story as well as others from our patients.